MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AFP; ALPHA-FETOPROTEIN

Catalog Number 03P36-30

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a falsely elevated afp result for one patient while using the architect afp assay.An afp test follow up was run after an ovarian cancer patient was admitted to the hospital.The customer provided the following data (ng/ ml): (b)(6) 2017: 1496.0 ng/ml.(b)(6) 2017: 281.0 ng/ml.(b)(6) 2017: ((b)(6)) 508.0 ng/ml, retested on (b)(6): 20.6 ng/ml.(b)(6) 2017: 19.3 ng.There was no adverse impact to patient management reported.

Manufacturer Narrative

Updated with additional information received 09/20/2017.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, batch record review, design history record (dhr) review, and a review of labeling.Tracking and trending did not identify an adverse trend or any atypical complaint activity.No issues were identified which would indicate a product deficiency from the batch record review.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information a deficiency of the architect afp reagent, list 03p36, lot 69132fn00 was not identified.

Event Description

Information was added to the event ticket to confirm that the patient is not pregnant.

• Brand Name: ARCHITECT AFP
• Type of Device: ALPHA-FETOPROTEIN
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer (Section G): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6835256
• MDR Text Key: 85139277
• Report Number: 3008344661-2017-00079
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P120008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2017
• Device Catalogue Number: 03P36-30
• Device Lot Number: 69132FN00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1